π‘ Biopharma Material Testing Ontology
Maturity: π‘ Provisional
IRI: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMaterialTesting/
RDF: BiopharmaMaterialTesting.rdf
This module supports representation of material testing activities used to determine whether a material is acceptable for its intended use. It connects testing processes, analytical evidence, specifications, acceptance criteria, out-of-specification results, and release dispositions so that material quality and suitability can be described consistently across incoming materials, process intermediates, consumables, and products.
Annotations
Copyright
Copyright (c) 2022, 2023, 2024, 2025, 2026 Open Applications Group
License
http://opensource.org/licenses/MIT
Classes (13)
| Class | Definition |
|---|---|
| culture media fingerprinting | measurement process in which a culture medium is characterized by one or more analytical methods to generate a multivariate profil⦠|
| material conformance specification | requirement specification that specifies tests and acceptance criteria for evaluating the acceptability of a material product, pro⦠|
| material conformance testing process | material testing process that evaluates a material product, process intermediate material, raw material, or production consumable β¦ |
| material hold state | material state during which a material entity remains restricted from one or more specified uses or handling activities |
| material performance testing process | material testing process that evaluates a capability of the input material entity through its use in a specified process or its ex⦠|
| material release disposition specification | material state specification that is a specified output of a material release process and specifies the post material state of the⦠|
| material release process | planned process in which a material entity, together with relevant evidence, is assessed against specified requirements to determi⦠|
| material stability testing process | material testing process that evaluates the capability of an input material entity to maintain one or more specified attributes or⦠|
| material test assessment | information content entity that records the outcome of evaluating measurement results against a specified testing criterion |
| material testing information content entity | information content entity that is the result of testing a material entity or one or more of its attributes against specified test⦠|
| material testing process | planned process that evaluates a material entity or one or more of its attributes against one or more specified testing criteria |
| out of specification assessment | material test assessment that records that one or more measurement results do not meet the acceptance criteria specified by an app⦠|
| spent culture media analysis | measurement process in which one or more attributes of material samples containing spent culture medium are measured to characteri⦠|
Table of contents
- π§ culture media fingerprinting
- π§ material conformance specification
- π§ material conformance testing process
- π§ material hold state
- π§ material performance testing process
- π§ material release disposition specification
- π§ material release process
- π§ material stability testing process
- π§ material test assessment
- π§ material testing information content entity
- π§ material testing process
- π§ out of specification assessment
- π§ spent culture media analysis